Hospal Tipstop
FDA 510(k) K982818 · Gambro Healthcare
510(k) numberK982818
Submission
- Device name
- Hospal Tipstop
- Applicant
- Gambro Healthcare
Lakewood, CO, US - Received
- August 11, 1998
- Decision date
- October 21, 1998
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- KMF – Bandage, Liquid
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 880.5090
- Specialty
- General Hospital
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| K131384 | Kericure Advanced Liquid Bandage, Natural Seal Liquid Bandage, Liquid BandageKMF · Traditional | Kericure, Inc. | 08/07/2014SE |
| K133443 | Marathon No Sting Liquid Skin ProtectantKMF · Traditional | Advanced Medical Solutions (Plymouth), Ltd. | 07/10/2014SE |
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More from Polichem S.A
| 510(k) | Device | Decision |
|---|---|---|
| K994390 | Gambro Polyflux 17R, Capillary Dialyzer/ FilterMSF · Traditional | 10/26/2000SE |
| K990039 | Gambro DQM 200LFP · Traditional | 01/27/2000SE |
| K982413 | Cobe Arylane H1, H4, H6 & H9 Hemodialyzers/FiltersKDI · Traditional | 04/21/1999SE |
| K982414 | Gambro Polyflux 11S, 14S, 17S & 21S Hemodialyzers/ HemofiltersKDI · Traditional | 03/26/1999SE |
| K980386 | Hospal Multiflow 100, Multiflow 100 Kits A0 (A0,A0/B and A0/0), Multiflow 100 Kits B22…KDI · Traditional | 02/24/1999SE |
| K982760 | Cobe C Hemodialysis Delivery System , Cobe Cartridge Blood Tubing SetKDI · Traditional | 11/04/1998SE |
| K974899 | Gambro Central Water Treatment System CWP 100 - Wro HFIP · Traditional | 09/23/1998SE |
| K981681 | Prisma CFM (Continuous Fluid Management System)KDI · Traditional | 08/11/1998SE |
| K981085 | Gambro Hemodialysis Water Treatment SystemFIP · Traditional | 05/18/1998SE |
| K970253 | Cobe Centrysystem 3 Dialysis Control Unit/Cobe Cartridge Blood Tubing SetKDI · Traditional | 09/26/1997SE |
Questions and answers
When was Hospal Tipstop cleared by the FDA?
Hospal Tipstop (K982818) received a 510(k) decision of Substantially Equivalent on October 21, 1998, 71 days after the submission was received.
What is the product code of K982818?
The FDA product code is KMF – Bandage, Liquid, a Class I (low risk) device regulated under 21 CFR 880.5090.